Abstract
Summary
Postmenopausal women with osteoporosis received 75 mg risedronate on two consecutive days each month or 5 mg daily for 12 months. Changes in bone mineral density and bone turnover markers were similar between treatments. Risedronate 75 mg twice monthly was effective and safe suggesting a new, convenient dosing schedule.
Introduction
Patients perceive less frequent dosing as being more convenient. This 2-year trial evaluates the efficacy and safety of a new monthly oral regimen of risedronate; 1 year results are presented here.
Methods
Postmenopausal women with osteoporosis (n = 1229) were randomly assigned to double-blind treatment with 75 mg risedronate on two consecutive days each month (2CDM), or 5 mg daily. The primary endpoint was the percent change from baseline in lumbar spine (LS) bone mineral density (BMD) at month 12. Secondary efficacy was evaluated by mean percent changes from baseline in BMD in LS, total hip, trochanter, and femoral neck, and bone turnover markers (BTMs).
Results
Risedronate 75 mg 2CDM was non-inferior to 5 mg daily (treatment difference 0.21; 95% CI -0.19 to 0.62). Mean percent change in LS-BMD was 3.4% ± 0.16 and 3.6% ± 0.15 respectively. Mean percent changes in BMD and BTMs were significant and similar for both treatment groups. New vertebral fractures occurred in 1% of subjects with either treatment. Both treatments were generally well tolerated and safe.
Conclusions
Risedronate 75 mg 2CDM was non-inferior in efficacy and did not show a difference in safety vs. 5 mg daily after 12 months, leading to a similar benefit.
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Acknowledgements
The following investigators participated in this study: Argentina: H. Salerni, L. Plantalech, C. Mautalen, Z. Man, J. Zanchetta; Australia: G. Nicholson, T. Diamond, P.S. Brook, S. Hall, P. Nach, J. Karash; Canada: L.G. SteMarie, J. Brown, D. Hanley, A. Hodsman, W. Olszynski, R. Josse, A. Kahn, J. Wade; Czech Republic: P. Kasalichy, V. Palicka, V. Kuba, V. Vyskocil; France: P.D. Delmas, G. Werhya, P. Fardellone, M. Laroche, C.L. Benhamou, M.C. DeVernejoul; United Kingdom: I. Caldwell, T. Maxwell, D. Dutchman; Poland: W. Tlustochowicz, J. Padzur, M. Korkosz, A. Fillopowivz-Sosnowska; Turkey: P. Yalcin, N. Parker, B. Gulekli, C. Yilmaz, N. Dursun; Lebanon: G. Maalouf; United States: M. McClung, M. Greenwald, R. Emkey, W. Ellison, S. Cohen, R. Weinstein, D. Fiske, R. Recker, R. Ackerman, H. Greisberg, J. Funk, T. Hennessey; South Africa: T.J. deVilliers, S. Lipschitz, G.C. Ellis, M. Davey, A.J. de Weerd, S. Hough.
Funding
Funding for this study was provided by the Alliance for Better Bone Health (Procter & Gamble Pharmaceuticals, Cincinnati, OH, USA, and sanofi-aventis, Paris, France). The authors received editorial/writing support in the preparation of this manuscript, funded by the Alliance for Better Bone Health. The authors were fully responsible for contents and editorial decisions for this manuscript.
Conflict of interest statement
Prof. P.D. Delmas has received consultant/honorarium fees and a research grant from Procter and Gamble/sanofi-aventis. Dr Benhamou has received advisory fees and for research grants from Amgen, Lilly, Merck, Novartis, Procter and Gamble, Roche, and Servier. Prof. Dr. Man has received consulting fees or advisory fees from Novartis and lectures fees from Aventis, sanofi-aventis and Roche. Dr. Tlustochowicz has received a research grant from Procter and Gamble/sanofi-aventis. Dr Matzkin is an employee of sanofi-aventis. Dr Eusebio is an employee of Procter and Gamble. Dr. Zanchetta has received consultant fees and/or research grants from Sanofi-Aventis, GlaxoSmithKline, Merck, Lilly, Wyeth, Amgen, Pfizer, Roche and Servier. Dr. Olszynski has received a research grant from Procter and Gamble/sanofi-aventis. Dr. Recker is a consultant for Merck, Lilly, Procter and Gamble, Wyeth, Amgen, Novartis, and Roche. Dr McClung has received consulting fees and research grants from Amgen, Lilly, Merck, Novartis, Procter and Gamble, Roche and sanofi-aventis.
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Delmas, P.D., Benhamou, C.L., Man, Z. et al. Monthly dosing of 75 mg risedronate on 2 consecutive days a month: efficacy and safety results. Osteoporos Int 19, 1039–1045 (2008). https://doi.org/10.1007/s00198-007-0531-9
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DOI: https://doi.org/10.1007/s00198-007-0531-9